Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With PD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
The goal of this clinical trial is to learn whether a 4-week effortful swallow exercise program helps adults with Parkinson disease who have swallowing problems. The effortful swallow is a swallowing exercise where a person swallows with extra effort.
Researchers will compare adults who start the exercise program right away with adults who start the program after a 4-week waiting period. All participants who remain eligible will have the opportunity to receive the exercise program.
Participants will have swallowing assessments, including video X-ray swallowing tests called videofluoroscopy. They will also complete questionnaires and take part in a remotely supervised swallowing exercise program with a speech-language pathologist. Participants who remain eligible and take part in the exercise program will use a tongue pressure device during practice. The main study period lasts about 10 weeks. Participants will also complete brief follow-up questionnaires at 6 months and 12 months.
Eligibility criteria
Qualifiers
Age 18 years or older
Neurologist-confirmed diagnosis of Parkinson disease
Self-report of one or more swallowing symptoms, such as difficulty managing secretions, coughing during meals, choking on food, or respiratory infection other than COVID-19 in the past 6 months
Baseline videofluoroscopic swallowing assessment showing prolonged time to laryngeal vestibule closure and/or poor pharyngeal area at maximum constriction on regular-effort swallows with thin or mildly thick liquid stimuli, relative to healthy reference values
Disqualifiers
History of head and neck cancer
History of radical neck dissection, anterior cervical spine surgery, or neck/oropharyngeal surgery, except tonsillectomy or adenoidectomy
History of any neurological disease other than Parkinson disease
Cognitive or receptive communication difficulties that preclude the ability to follow English-language study instructions
Trial design
Treatments tested in this trial
- Effortful swallow
Treatment groups
74 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov